510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812538Substantially Equivalent

Elite

Biotone International, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812538 is the FDA 510(k) clearance record for ELITE, a class II device, cleared for Biotone International, Inc. on under FDA product code IPF (Stimulator, Muscle, Powered). FDA records list 4 510(k) clearances for Biotone International, Inc., from to . As of , FDA records show no recalls naming K812538.

Clearance record

Decision date
Received
(89 days to decision)
Product code
IPF Stimulator, Muscle, Powered
Regulation
21 CFR 890.5850
Device class
Class II
Review panel
Physical Medicine
Applicant
Biotone International, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code IPF

Trailing 12 months
3 clearances under product code IPF in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code IPF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20262
July 20260
August 20260
September 20260
October 20260